UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
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`In the Matter of
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`CERTAIN DISPOSABLE VAPORIZER
`DEVICES AND COMPONENTS AND
`PACKAGING THEREOF
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`Inv. No. 337-TA-
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`Docket No. 3700
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`COMPLAINANTS’ RESPONSE TO THE SUBMISSION OF THE UNITED STATES
`FOOD AND DRUG ADMINISTRATION
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`Complainants respond to the U.S. Food and Drug Administration’s (“FDA”) submission
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`regarding certain of Complainants’ Lanham Act claims.1 Complainants respectfully submit that the
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`FDA is mistaken as to its conclusion that Complainants’ first Lanham Act claim is precluded.
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`First, Complainants are seeking to protect America’s youth by arresting the flood of foreign
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`candy and dessert flavored disposable vapes targeting minors. This investigation is necessary because
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`FDA has not made a dent in this unlawful trade.2
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`Second, FDA is wrong that Complainants’ first false advertising claim is precluded by the
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`FDCA. Relying on Amarin Pharma, Inc. v. ITC, 923 F.3d 959 (Fed. Cir. 2019) (“Amarin”), FDA’s
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`over-broad interpretation of preclusion runs afoul of controlling law. See POM Wonderful v. Coca-
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`Cola Co., 573 U.S. 102 (2014) (rejecting FDA’s position that Lanham Act claims were barred on
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`FDA regulated product as “a bridge too far” and for seeking a “reorder[ing] federal statutory rights
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`without congressional authorization.”). The Supreme Court held “the FDCA and the Lanham Act
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`complement each other in the federal regulation of misleading labels” and that the FDCA permits
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`Lanham Act claims related to labels subject to the FDCA’s regulatory scheme. Id. Under POM
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`Wonderful there is a “general presumption … that Lanham Act claims with regard to FDCA-regulated
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`products are permissible and, indeed, desirable.” JHP Pharm., LLC v. Hospira, Inc., 52 F.Supp.3d
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`992, 1000 (C.D. Cal. 2014) (emphasis added).
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`Consistent with POM Wonderful, Complainants’ first false advertising claim is not precluded
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`because it does not require the Commission to make a determination that “l[ies] at the heart of the”
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`1Complainants assert three distinct false advertising claims. See ¶¶120-136; ¶¶137-142; ¶¶143-
`147. FDA only claims the first is preempted. FDA explicitly agrees that the second claim (relating
`to “clear”) and third claim (relating to Animated Character Marks and works) are not precluded
`because they do not implicate the FDCA. Thus, a private cause of action does exist.
`2 Despite FDA’s claim (at 5) that it “is in fact deploying the advisory and enforcement tools at its
`disposal,” these dangerous vapes continue to flood the market unabated. Complaint Ex. 58.
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`1
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`FDA or requires “agency expertise … to unravel intricate, technical facts Complainants claims have
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`been explicitly allowed in previous actions.” See, e.g., Azurity Pharma, Inc. v. Edge Pharma, LLC,
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`45 F.4th 479 (1st Cir. 2022). Indeed, the “FDA’s choice not to enforce the terms” of its own guidance
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`“does not mean that the terms of the [FDCA] provision are less than perfectly clear.” Id. at 502.
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`Tellingly, the FDA does not cite a specific regulation or definition that the Commission would need
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`to interpret in resolving whether the accused vapes are authorized by the government. That is because
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`Complainants are explicitly not seeking to step into the shoes of the FDA to directly or indirectly
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`enforce the FDCA by having the Commission declare that products are “illegal” under that act. Rather
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`they seek to enforce their Lanham Act rights to stop Proposed Respondents from falsely advertising
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`that their products have the imprimatur of government authorization.3
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`Nothing in Complainants’ first claim requires any interpretation of the FDCA because not
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`even FDA disputes that Proposed Respondents’ products are “unlawful” and “lack … authorization”
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`as defined in the Complaint. FDA Letter at 2, 4. If Proposed Respondents have a marketing order,
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`they can produce it. If they timely filed a PMTA that remains pending with FDA, they can prove it.
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`Thus, controlling Supreme Court authority provides that the claim is not precluded. POM Wonderful,
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`573 US at 120 (it is insufficient to preclude a Lanham Act claim even though the FDA “enacted
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`regulations that touch on similar subject matter but do not purport to displace that remedy….”).4
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`3 This is also why Complainants’ products are not “illegal” as defined in the Complaint. See FDA
`Ltr at 5. Complainants’ products are not youth marketed, they are subject to robust measures to
`prevent youth access, and Complainants’ on-market vapes all have a marketing granted order, a
`timely filed application pending with FDA, or a stayed marketing denial order.
`4 FDA asserts that it is “difficult” to determine “whether a product has a marketing application”
`because “FDA is required to keep [that fact] confidential.” Id. But FDA has already published a
`list of vapes subject of timely filed applications and on the market as of August 8, 2016. FDA,
`Deemed New tobacco Product Applications Lists, https://shorturl.at/aoCOS. If a product is already
`on the market (like the Accused Products), any concern falls away. Nothing precludes a respondent
`from producing evidence that its products are the subject of a timely filed application.
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`2
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`Third, denial of institution would be contrary to, and irreconcilable with, the Commission’s
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`institution decision in Certain Potassium Chloride Powder Prods., Inv. No. 337-TA-1013 (2016).5
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`This case is distinguishable from Amarin and analogous to Potassium Chloride where the gravamen
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`of that investigation was an assertion that respondents falsely advertised and promoted “unapproved”
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`products as “FDA Approved.” This is no different than what Complainants’ first false advertising
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`claim asserts. The Potassium Chloride complaint alleged that the respondents falsely and deceptively
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`marketed their drugs as FDA-approved in violation of the Lanham Act and the FDCA, when in fact
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`the complainants had the only FDA-approved drug of that type on the market. There, respondents
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`advanced the exact argument FDA does here – that the ITC should not institute an investigation
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`because doing so would “usurp the exclusive regulatory power of FDA” and “encroach on the FDA’s
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`authority under the FDCA.” Certain Potassium Chloride Powder Prods., Inv. No. 337-TA-1013,
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`Resp’ts’ Public Interest Comments at 2–4, EDIS Doc. ID 585380 (July 7, 2016). Nonetheless, the
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`ITC determined that institution was proper in that case despite a preclusion argument. See id. Notice
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`of Institution, 81 FR 49263 (July 21, 2016). Thus, this investigation should be instituted like Inv.
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`1013.
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`Unlike the Amarin products, the Potassium Chloride accused drugs were unquestionably not
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`FDA approved, so the Commission did not need to resolve any questions that required the FDA’s
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`expertise before reaching the merits of the Lanham Act arguments. The same is true here. There is
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`no dispute that Proposed Respondents’ vapes are not allowed for sale in the United States. See FDA
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`Letter at 2. Instituting this investigation, as was done under nearly identical facts in Potassium
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`Chloride, would also be consistent with the Commission’s prior institution decisions in similar ITC
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`5 OUII agreed that FDCA preclusion does not apply where a Lanham Act claim based on whether
`an accused product is FDA approved. Staff Resp. to Resp’ts. MSD of FDCA Preclusion, Potassium
`Chloride, Inv. No. 337-TA-1013, EDIS Doc. ID 593245 at 4 n.2 (Oct. 21, 2016).
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`3
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`cases.6
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`These Commission institution decisions relate to the “approval” and “lawfulness” of products,
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`just like Complainants’ first false advertising claim, and are entirely consistent with the
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`overwhelming weight of cases which have found that Lanham Act claims relating to “approval” of a
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`FDA regulated product are simply not subject to preclusion.7 This voluminous caselaw is particularly
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`6 Certain Clidinium Bromide, Inv. No. 337-TA-1109 (Apr. 23, 2018) (Lanham Act claim based on
`fact that respondents drug was not FDA approved and was unlawful); Certain Periodontal Laser
`Devices, Inv. No. 337-TA-1070 (Sept. 11, 2017) (false advertising, in part, due to lack of FDA
`regulatory clearance of laser dental devices); Certain Light Emitting Diode Prods., Inv. No. 337-
`TA-947, Initial Determination at 425 (Sept. 2, 2016) (rejecting argument that EPA labeling
`regulations precluded Lanham Act claim, stating “[the ITC] has frequently exercised its authority
`with respect to Lanham Act violations based on the failure to meet and follow requirements set by
`other federal agencies.”)
`7 See e.g., Pom Wonderful 573 U.S. at 120-21 (rejecting FDA’s position that it can categorically
`preclude Lanham Act claims over the labeling of FDCA-regulated products and stating “Congress
`did not intend the FDCA to preclude Lanham Act suits” alleging false and misleading advertising);
`Azurity, 45 F.4th at 502 (no false advertising preclusion); Belcher Pharms., LLC v. Hospira, Inc.,
`1 F.4th 1374, 1381 (11th Cir. 2021) (no preclusion on Lanham Act claim that defendants gave
`“false impression” that their products “were approved by the FDA”); Thermolife Int’l, LLC v.
`Gaspari Nutrition Inc. 648 Fed. Appx. 609, 612 (9th Cir. 2016) (allegations that defendant had
`falsely advertised a “dietary supplement” as “safe,” “natural,” and “legal” were not precluded by
`the FDCA); Allergan Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir. 2013) (finding no
`preemption of California’s unfair competition law by FDCA where allegation was that defendant
`had not obtained approval of product as a “drug,” and that defendant was marketing an unapproved
`“drug” as a “cosmetic”); Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 936, 939 (8th Cir.
`2005) (reversing dismissal of Lanham Act claim against advertising antibiotic animal feed additive
`as “approved” when it was not and holding preclusion did not apply); Rhone-Poulenc Rorer
`Pharma., Inc. v. Marion Merrell Dow, Inc., 93 F.3d 511 (8th Cir. 1996) (affirming viability of
`Lanham Act claims concerning representations of FDA approval of a drug); Ciccio v.
`Smiledirectclub, LLC, 2022 WL 843774, *8 (M.D. Tenn. Mar. 21, 2022) (false advertising that
`implied that defendants dental aligners were “FDA cleared or approved” not precluded and not
`subject to Amarin); Method Pharms., LLC v. H-2 Pharma, 2022 WL 327738, *9 (M.D. Ala. Feb.
`3, 2022) (misleading representation by omission that FDA regulated drugs are FDA-approved
`when they are not is not precluded); Innovative Health Sols., Inc. v. DyAnsys, Inc., 2015 WL
`2398931, *7 (N.D. Cal. May 19, 2015) (allegations “that defendants have falsely represented that
`they obtained FDA approval for their products … are not precluded or preempted.”); JHP Pharms.,
`LLC v. Hospira, Inc., 52 F. Supp. 3d 992, 999, 1001 (C.D. Cal. 2014) (claim that defendants
`misrepresented their products as being FDA-approved is not precluded and stating “Lanham Act
`claims (even with regard to FDA approval) are not, as a general matter, precluded or barred by the
`FDCA”); Par Sterile Prod., LLC v. Fresenius Kabi USA LLC, 2015 WL 1263041, *4 (N.D. Ill.
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`4
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`instructive in that, unlike the authority relied upon by opposing parties, it directly addresses the issue
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`of FDA “approval” in the context of Lanham Act claims and finds no preclusion.
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`Fourth, the FDA is simply wrong as a factual matter that Complainants’ first false advertising
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`claim would require an interpretation or application of the FDCA. No interpretation of the FDCA or
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`any FDA regulation is required at all.8 Even the Amarin Court recognized that a Lanham Act claim
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`should not be precluded “where FDA has provided guidance as to whether … particular articles
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`violate the FDCA.” 923 F.3d at 963 n.1 Thus, FDA’s reliance on Amarin, 923 F.3d 959, is therefore
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`misplaced because the false advertising claim there turned on the Commission having to decide the
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`legal question whether the accused products were “dietary supplements” or “drugs” as defined by the
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`FDCA. Here, no such legal interpretation is needed as FDA tacitly admits.9
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`Fifth, in any event, making a determination on the merits of Complainants’ claims by denying
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`institution is improper at this stage. There are factual issues as to Proposed Respondents’ statements,
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`advertising, consumers’ perceptions of that false advertising, and the applications of these facts to the
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`law. Thus, the Commission should institute an investigation on all claims and have a complete
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`evidentiary record before determining whether FDCA preclusion applies.
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`Mar. 17, 2015) (“the FDCA does not preclude Lanham Act claims” that “defendant
`misrepresented that its product was FDA approved”).
`8 Alpharma, Inc., 411 F.3d at 939 (“The question of whether [the defendant’s product] has been
`approved as safe and effective is much different from the question of whether [the defendant’s
`product] should be approved as safe and effective, and it is only the latter that requires the FDA’s
`scientific expertise.”) (emphases added).
`9 It is no defense that federal law requires tobacco products to include the disclaimer, “sale only
`allowed in the United States.” See 21 U.S.C. § 387t(a). A manufacturer is still liable under the
`Lanham Act when it engages in false advertisement. See Wyeth v. Levine, 555 U.S. 555 (2009)
`(rejecting the very type of “pre-approval argument” FDA advances here).
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`5
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`November 1, 2023
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`Respectfully submitted,
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`______________________________
`Harold H. Davis
`GREENBERG TRAURIG, LLP
`101 Second Street
`San Francisco, CA 94105
`Telephone: (415) 655-1300
`Facsimile: (415) 707-2010
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`Rosa S. Jeong
`Cyrus T. Frelinghuysen
`Gregory J. Winter
`GREENBERG TRAURIG, LLP
`2101 L Street, N.W.
`Washington, DC 20037
`Telephone: (202) 331-3100
`Facsimile: (202) 331-3100
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`Elli Leibenstein
`Kevin D. Finger
`Emily A. Sickelka
`GREENBERG TRAURIG, LLP
`77 West Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 456-8400
`Facsimile: (312) 456-8435
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`Andrea S. Ferraro
`Matthew A. Richard
`GREENBERG TRAURIG, P.A.
`777 S. Flagler Street, Suite 300 East
`West Palm Beach, FL 33401
`Telephone: (561) 650-7900
`Facsimile: (561) 655-6222
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`Counsel for Complainants R.J. Reynolds
`Tobacco Company and R.J. Reynolds Vapor
`Company
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`6
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